FDA.reportPublic FDA data

CVS Health

Primary DI
20050428369177
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
893128
Device description
Premium Roll Gauze, 5 rolls, 3 IN x 2.1 YDS (7.6 cm x 1.9 m) Unstretched
Published
2020-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20050428369177PackageGS136In Commercial Distribution
00050428369173PrimaryGS10
60050428369175Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042836917720050428369177
00050428369173000504283691730504283691730050428369173
6005042836917560050428369175

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll, sterileA sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18007467287xx@xx.xx

Regulatory Flags#

DUNS number
062312574
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
20050428020849CVS HealthCVS376561V22026-03-23
00050428339770CVS Health16CVS015073291982026-03-20
10050428001025CVS 797412BM22-12026-02-27
00050428005408CVS 841855WF032026-02-13
00050428005415CVS 845712WF132026-02-13
00050428005422CVS 837160WF232026-02-13
40050428029495CVS6354782026-02-13
00050428057186CVSHealth1017042026-02-04
00050428073421CVSHealth1044172026-02-04
00050428080863CVSHealth1059932026-02-04
00050428005583CVS 689466LB152026-01-28
10050428005603CVS 689509LB262026-01-26
10050428005610CVS 689573LB462026-01-23
10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
00050428005804CVS 275172BF7222025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979109839986GAUZE SWABSXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-03-16
20763000888989MerocelMEDTRONIC XOMED, INC.NAB2026-03-08
20763000888996MerocelMEDTRONIC XOMED, INC.NAB2026-03-08
00851587006073XGAUZE Trauma PadRevmedx, Inc.NAB2026-02-25
20665973020918DukalDukal LLCNAB2026-01-30
20665973020932DukalDukal LLCNAB2026-01-30
00810194401763AiraAIRA, LLCNAB2026-01-16
00810194401770AiraAIRA, LLCNAB2026-01-16
00810194401787AiraAIRA, LLCNAB2026-01-16
00810194401824AiraAIRA, LLCNAB2026-01-16
00810194401831AiraAIRA, LLCNAB2026-01-16
00810194401848AiraAIRA, LLCNAB2026-01-16
00810194401855AiraAIRA, LLCNAB2026-01-16
00723896029558Practicon® Standard 2x2 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029589Practicon® Premium 2x2 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029619Practicon® Standard 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029640Practicon® Premium 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00840456217009JMUJMU DENTAL, INCNAB2025-12-31
00840456217856JMUJMU DENTAL, INCNAB2025-12-31
00840456217863JMUJMU DENTAL, INCNAB2025-12-31
06931918102354AllesetGRI Medical & Electronic Technology Co., Ltd.NAB2025-12-16
10815555025593CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025609CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025715CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025616CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025692CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025708CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
08809968572930Soosung Non-Woven Fabricsoosung medicalNAB2025-12-10
08809968572954Soosung Non-Woven Fabricsoosung medicalNAB2025-12-10
08809968572978Soosung Non-Woven Fabricsoosung medicalNAB2025-12-10