FDA.reportPublic FDA data

GCB Medical Supply

Primary DI
00850061859211
Brand
GCB Medical Supply
Company
GCB MEDICAL LLC
Model
GCB0213
Catalog number
GCB0213
Device description
GCB MEDICAL SURGEON CAP PREMIUM
Published
2025-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061859211PackageGS1100In Commercial Distribution
00850061859204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061859211008500618592118500618592110850061859211
00850061859204008500618592048500618592040850061859204

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8334226331info@gcbmedicalsupply.com

Regulatory Flags#

DUNS number
086699722
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00810184642152GCB Medical SupplyGCBIVT055BGCBIVT055B2026-01-28
00810184642169GCB Medical SupplyGCBIVT056BGCBIVT056B2026-01-28
00810184642176GCB Medical SupplyGCBIVT057BGCBIVT057B2026-01-28
00810184642213GCB Medical SupplyGCBIVT055BGCBIVT055B2026-01-28
00810184642220GCB Medical SupplyGCBIVT056BGCBIVT056B2026-01-28
00810184642237GCB Medical SupplyGCBIVT057BGCBIVT057B2026-01-28
00810184641292GCB Medical SupplyGCB941GCB9412025-07-31
00810184641308GCB Medical SupplyGCB941XLGCB941XL2025-07-31
00810184641315GCB Medical SupplyGCB942GCB9422025-07-31
00810184641667GCB Medical SupplyGCB941GCB9412025-07-31
00810184641674GCB Medical SupplyGCB941XLGCB941XL2025-07-31
00810184641681GCB Medical SupplyGCB942GCB9422025-07-31
00810184641322GCB Medical SupplyGCB0287GCB02872025-07-29
00850061859006GCB Medical SupplyGCB0288GCB02882025-07-29
00850061859228GCB Medical SupplyGCBHW002GCBHW0022025-07-29
00810184641698GCB Medical SupplyGCB0287GCB02872025-07-29
00850061859105GCB Medical SupplyGCB0288GCB02882025-07-29
10850061859225GCB Medical SupplyGCBHW002GCBHW0022025-07-29
00810184640974GCB Medical SupplyGCB0210BXGCB0210BX2025-07-24
00810184640981GCB Medical SupplyGCB0212GCB02122025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536901100BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901117BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901124BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901131BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901148BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901155BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901162BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901179BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901186BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
10840330706671ProCureTwin Med, LLCFYF2026-05-05
20197344202215MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
20680651497271HalyardO&M HALYARD, INC.FYF2025-10-24
TQ26126151701Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126151991Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126152001Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
10810141933238VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933245VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933252VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933269VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933276VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933283VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933290VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933306VIVIT SupplyVivit Supply LLCFYF2024-11-29
10097604414033Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604419014Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604455029Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604474112Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
20197344099945MedlineMEDLINE INDUSTRIES, INC.FYF2024-04-11
20197344036483MedlineMEDLINE INDUSTRIES, INC.FYF2023-12-19
30884389102590MedlineMEDLINE INDUSTRIES, INC.FYF2023-10-13