FDA.reportPublic FDA data

Hart Medical - Normed - Splinter Out

Primary DI
00000981080008
Brand
Hart Medical - Normed - Splinter Out
Company
MediPoint Holdings LLC
Model
7320
Published
2023-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTFCurette

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650332732010PrimaryGS10
00000981080008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650332732010006503327320106503327320100650332732010
00000981080008000009810800080009810800080000981080008

GMDN Terms#

Term, Definition table
TermDefinition
Dermal curetteA sterile, hand-held manual surgical instrument designed exclusively for the precise scraping and/or excising of skin/dermal tissue (e.g., for treatment of superficial warts or wounds). It is available in a variety of shapes/sizes and has an appropriately-shaped distal end (e.g., ring-like). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118797353
Device count
10
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

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
00098108000008Splinter Out199502023-03-29
00098108195711Medipoint Blood Lancets195702002023-02-01
00098108195728Medipoint Blood Lancets1957010002023-02-01
00098108195773Medipoint195702022-10-14
00098108195780Medipoint195712022-10-14
00098108000015Medipoint195712022-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160384816CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2025-01-25
10653160382133CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-11-08
10653160382140CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-11-08
10653160374862CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-05-18
08806395489848PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
08806395489855PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
08806395489862PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
10653160357506CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2023-01-13
07898506841431QuinelatoSchobell Industrial LtdaHTF2023-01-10
07898506845439QuinelatoSchobell Industrial LtdaHTF2023-01-10
07898506848447QuinelatoSchobell Industrial LtdaHTF2023-01-10
07898506841929QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506841967QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506848935QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506848942QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506849260QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506849314QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506853793QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506853809QuinelatoSchobell Industrial LtdaHTF2023-01-09
EZPF41891040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-16
EZPF4185501ZS0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-08
10653160351368CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351382CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351399CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351429CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351474CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160307334CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-02
10653160278795CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01
10653160279846CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01
10653160279853CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01