FDA.report

4WEB Medical

Primary DI
00810074752510
Brand
4WEB Medical
Company
4web Medical
Model
HTS-KIT003-SP
Catalog number
HTS-KIT003-SP
Published
2022-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KDDKit, Surgical Instrument, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810074752510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810074752510008100747525108100747525100810074752510

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
021323706
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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