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Device Explorer · FDA GUDID · GMDN 58931

Non-antimicrobial wound irrigation solution, multiple solute

A solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide ant

US‑registered devices106in commercial distribution
Companies17labelers on GUDID
Single‑use12%of device records
Sterile3%labelled sterile
Prescription43%Rx‑only share
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Share of device records

Sonoma Pharmaceuticals, Inc.4542%
Mckesson Medical-Surgical Inc.109%
Hr Pharmaceuticals Inc.88%
Century Pharmaceuticals Inc88%
Urgo Medical North America, Llc77%
Asept Pak, Inc.66%
P.G.F. Industry Solutions Gmbh55%
Osartis Gmbh33%

Top labelers

CompanyDevicesShare
Sonoma Pharmaceuticals, Inc.4542%
Mckesson Medical-Surgical Inc.109%
Hr Pharmaceuticals Inc.88%
Century Pharmaceuticals Inc88%
Urgo Medical North America, Llc77%
Asept Pak, Inc.66%
P.G.F. Industry Solutions Gmbh55%
Osartis Gmbh33%
Cardinal Health 200, Llc33%
Synedgen, Inc.22%
Woonsocket Prescription Center, Incorporated22%
Derma Sciences Canada Inc22%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BioWash Surgical IrrigationXPERIENCE Advanced Surgical IrrigationCARDINAL HEALTH ESSENTIALSLasercyn Dermal SprayLevicyn Dermal SprayMicrocyn Skin & Wound CareEpicyn Facial CleanserPhaseOne Antimicrobial SolutionMicrocyn OTC Wound & Skin CleanserCLEAR-LOCK CERAMICSynePure Wound CleanserVashe Wound Solution 1 L (34 fl oz) InstillationVashe Wound Solution 1 L (34 fl oz) Flip Top ConVashe Wound Solution 475 ml (16 fl oz) InstillatVashe Wound Solution 250 ml (8.5 fl oz) InstillaVashe Wound Solution 475 ml (16 fl oz) Flip Top

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FRODressing, Wound, Drug96
FRODressing, wound, drug11
FQHLavage, Jet6
MGPDRESSING, WOUND AND BURN, OCCLUSIVE2
NJMBracket, Ceramic, Orthodontic1
FQHLAVAGE, JET1

GMDN & GCC registration

  • GMDN code 58931 · non‑implantable
  • Single‑use 12% · sterile 3% · Rx‑only 43% · OTC 49%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 50Total Volume (Fluid Ounce) · 11Total Volume (Liter) · 2

Use these as the dimensions to specify in a tender line.

How many non-antimicrobial wound irrigation solution, multiple solute products are registered in the US?

106 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-antimicrobial wound irrigation solution, multiple solute", from 17 companies. The largest labeler is Sonoma Pharmaceuticals, Inc. with 42% of records.

Which FDA product codes apply?

FRO (Dressing, Wound, Drug), FRO (Dressing, wound, drug), FQH (Lavage, Jet), MGP (DRESSING, WOUND AND BURN, OCCLUSIVE)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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