FDA.reportPublic FDA data

Medipoint

Primary DI
00098108195780
Brand
Medipoint
Company
MediPoint Holdings LLC
Model
19571
Published
2022-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GESBlade, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00098108195780PrimaryGS10
00098108000015Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00098108195780000981081957800981081957800098108195780
00098108000015000981080000150981080000150098108000015

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Regulatory Flags#

DUNS number
118797353
Device count
200
Premarket exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00098108000039SPLINTER OUTSplinter Out Kit - 282025-07-10
00098108000022Actuvate Splinter Out98108199078 ACT2023-09-29
00098108199054Splinter Out199052022-09-28
00098108199061Splinter Out 199062022-09-28
00098108199078Splinter Out199072022-09-28
00098108199559Splinter Out199502023-03-29
00650332732010Hart Medical - Normed - Splinter Out73202023-09-29
00738743224109ACME UNITED SPLINTER OUT22-4102023-09-29
00843484122499EVER READY SPLINTER OUT REMOVER 19907-ER2023-06-14
00843484122505EVER READY SPLINTER OUT REMOVER19906-ER2023-06-14
00000981080008Hart Medical - Normed - Splinter Out73202023-09-29
00098108000008Splinter Out199502023-03-29
00098108195711Medipoint Blood Lancets195702002023-02-01
00098108195728Medipoint Blood Lancets1957010002023-02-01
00098108195773Medipoint195702022-10-14
00098108000015Medipoint195712022-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459343513MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GES2025-05-22
08717903490228Humeca blade for Silver knifeHumeca B.V.GES2025-05-20
08717903490242Humeca blade for Humby long knife (20cm/7.9 in)Humeca B.V.GES2025-05-20
08717903490235Humeca blade for Humby, Cobbett and Watson knives (16 cm/6.3 in)Humeca B.V.GES2025-05-19
10888277384224MEDLINEMEDLINE INDUSTRIES, INC.GES2025-02-14
10888277391857MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-30
10888277383395MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10888277385115MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10850053289818SurgycoSurgyco LLCGES2024-12-20
10850053289825SurgycoSurgyco LLCGES2024-12-20
10850053289832SurgycoSurgyco LLCGES2024-12-20
10850053289849SurgycoSurgyco LLCGES2024-12-20
10850053289856SurgycoSurgyco LLCGES2024-12-20
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