FDA.reportPublic FDA data

AllCare

Primary DI
00182921000090
Brand
AllCare
Company
ALLCARE, INC
Model
AG4416X-10
Catalog number
AG4416X-10
Device description
"SPONGE GAUZE X-RAY DETECTABLE, 4""X4"", 16 PLY, 10/PK STERILE "
Published
2020-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30182921000091PackageGS1128In Commercial Distribution
00182921000090PrimaryGS10
00182921000113Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3018292100009130182921000091
00182921000090001829210000901829210000900182921000090
00182921000113001829210001131829210001130182921000113

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque woven surgical spongeA non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
630-830-7486qra@allcaredirect.com

Regulatory Flags#

DUNS number
362187580
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10182921000127AllCareAG4412AG44122022-04-06
00182921000656ALLCARECK813 CK813 2022-06-05
00182921000670ALLCARECK613CK6132022-06-05
00182921000618AllCarePL3002022-04-06
00182921000533AllCare, INCPL200PL2002022-04-06
10182921000745ALLCAREPJ13011 PJ13011 2022-12-08
10182921000769ALLCAREPK10011PK100112022-12-08
00182921000403ALLCAREPA31261 PA31261 2022-12-03
00182921000076ALLCAREPA31261 PA31261 2022-12-03
10182921000684ALLCAREEB500BEB500B2022-11-27
10182921000851ALLCAREFS100 FS100 2022-11-27
10182921000868ALLCAREEF600PEF600P2022-11-27
10182921000875ALLCAREEF700EF7002022-11-27
00182921000397AllCareEF601XEF601X2022-11-27
00182921000885AllCareEF601XEF601X2022-11-27
00182921000687ALLCAREEB500BEB500B2022-11-27
00182921000854ALLCAREFS100 FS100 2022-11-27
00182921000861ALLCAREEF600PEF600P2022-11-27
00182921000878ALLCAREEF700EF7002022-11-27
00182921000793AllCareER600ER6002022-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536924000BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924024BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924031BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924055BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
00850049994866SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994873SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994880SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994897SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994903SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994910SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994927SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994934SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994941SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994958SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994965SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994972SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994996SynterventionZien Medical Technologies, LLCGDY2025-09-23
00850049994989SynterventionZien Medical Technologies, LLCGDY2025-09-22
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10810178830005Tally Surgical SolutionTally Surgical, Inc.GDY2025-02-18
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119528Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119535Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119542Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09