FDA.reportPublic FDA data

Health Care Logistics, Inc®

Primary DI
10827989003641
Brand
Health Care Logistics, Inc®
Company
Health Care Logistics, Inc.
Model
12078
Device description
Bouffant Cap
Published
2025-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10827989003641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082798900364110827989003641

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

Regulatory Flags#

DUNS number
092159383
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827989008137SAFEVIEWSV250L129362026-07-10
00827989008243MedSafety7857-107857-102026-07-10
00827989008250SharpSafety8900SA96042026-07-10
00827989008281Health Care Logistics, Inc®21046210462026-07-10
00827989008298Health Care Logistics, Inc®21046-3121046-312026-07-10
00827989008175Topi-CLICKTC35 White178952026-06-15
00827989008106Health Care Logistics, Inc®188242026-06-10
00827989008090Health Care Logistics, Inc®74462026-06-09
00827989008076Health Care Logistics, Inc®DMP-BCSK2026-04-21
00827989008069Health Care Logistics, Inc®MOD-1299922026-04-13
00827989008021Health Care Logistics, Inc®MOD-1295722026-03-24
00827989008038Health Care Logistics, Inc®MOD-1295772026-03-24
00827989008045Health Care Logistics, Inc®MOD-1295802026-03-24
00827989008052Health Care Logistics, Inc®MOD-1295812026-03-24
00827989007857Health Care Logistics, Inc®213052026-03-13
00008279897857Health Care Logistics, Inc®213052026-01-29
00827989007970Chemo Vent31-50187232026-03-04
00827989007987Venting Needle31-20189552026-03-04
00827989007963Health Care Logistics, Inc®20337203372026-02-25
00827989007956Health Care Logistics, Inc®19934199342026-02-12

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