SCALPEL, ONE-PIECE

GUDID 00860009716131

Jhk, Inc.

Scalpel, single-use
Primary Device ID00860009716131
NIH Device Record Keyd529d13b-7ae4-4b0f-8a4e-9d1dd3991fa1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCALPEL, ONE-PIECE
Version Model Number1512, 1510, 1515
Company DUNS867236309
Company NameJhk, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009716131 [Primary]

FDA Product Code

GDXSCALPEL, ONE-PIECE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-07
Device Publish Date2023-07-28

Devices Manufactured by Jhk, Inc.

00860009716179 - ELASTIC BANDAGE2023-08-07
00860009716117 - EXTRACTOR, SPLINTER REMOVER2023-08-07
00860009716155 - SPRAY / PUMP2023-08-07
00860009716131 - SCALPEL, ONE-PIECE2023-08-07
00860009716131 - SCALPEL, ONE-PIECE2023-08-07
00860009716148 - GAUZE / SPONGE, NONRESORBABLE FOR EXTERNAL USE2023-08-07
00860009716162 - PACK, HOT OR COLD, DISPOSABLE2023-08-07
00860009716193 - TAPE AND BANDAGE, ADHESIVE2023-08-07

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