FDA.report

Pomee

Primary DI
G1577043950
Brand
Pomee
Company
POMEE CORPORATION
Model
704-395
Catalog number
704-395
Device description
Silver point forceps 5" grooved
Published
2021-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
EMDHemostat, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G1577043950PrimaryHIBCC0

GMDN Terms

TermDefinition
Tooth extraction forcepsA hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
645717646
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G1577078910Pomee707-891707-8912025-06-14
G1577078920Pomee707-892707-8922025-06-14
G157PCAH0PomeePCAHPCAH2024-07-05
G157PCAP0PomeePCAPPCAP2024-07-05
G157PCAT0PomeePCATPCAT2024-07-05
G157PCAV0PomeePCAVPCAV2024-07-05
G1577025400Pomee702-540702-5402023-10-18
G1577025450Pomee702-545 702-5452023-10-18
G1577025500Pomee702-550702-5502023-10-18
G1577072950Pomee707-295707-2952023-10-18
G1577073000Pomee707-300707-3002023-10-18
G1577073050Pomee707-305707-3052023-10-18
G1577073100Pomee707-310707-3102023-10-18
G1577078100Pomee707-810707-8102023-10-18
G1577078120Pomee707-812707-8122023-10-18
G1577078150Pomee707-815707-8152023-10-18
G1577078170Pomee707-817707-8172023-10-18
G1577078200Pomee707-820707-8202023-10-18
G1577078250Pomee707-825707-8252023-10-18
G1577078300Pomee707-830 707-830 2023-10-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G1493806608TBS DentalACME ENTERPRISE.EMD2026-03-02
G1493807609TBS DentalACME ENTERPRISE.EMD2026-03-02
00841336101630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
00841336101647Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
00840343726287GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726379GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726386GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726393GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343725884GEN2SURGIX MEDICAL LLCEMD2025-03-07
00842517111417Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517111424Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112209Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112216Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
D928140051190HEMOSTAT CRAFOORD SLIGHT CURVED 19CMW.H. Holden, Inc.EMD2024-12-18
00840343725099GEN2SURGIX MEDICAL LLCEMD2024-11-07
00840343724702GEN2SURGIX MEDICAL LLCEMD2024-10-25
00840343724061GEN2SURGIX MEDICAL LLCEMD2024-10-01
00840343724078GEN2SURGIX MEDICAL LLCEMD2024-10-01
00840343723255GEN2SURGIX MEDICAL LLCEMD2024-09-18
00840343723392GEN2SURGIX MEDICAL LLCEMD2024-09-12
00348783001440Premier HemostatPREMIER DENTAL PRODUCTS COMPANYEMD2024-08-01
00348783001457Premier HemostatPREMIER DENTAL PRODUCTS COMPANYEMD2024-08-01
00840343722913GEN2SURGIX MEDICAL LLCEMD2024-07-31
00840343722968GEN2SURGIX MEDICAL LLCEMD2024-07-31
00840343722999GEN2SURGIX MEDICAL LLCEMD2024-07-31
00813677023230PDT, Inc.PDT, INC.EMD2024-07-02
04049197054799RZ Medizintechnik GmbHRZ-Medizintechnik GmbHEMD2024-07-01
00840343722814GEN2SURGIX MEDICAL LLCEMD2024-06-28
04049197206495RZ Medizintechnik GmbHRZ-Medizintechnik GmbHEMD2024-06-28
04049197206693RZ Medizintechnik GmbHRZ-Medizintechnik GmbHEMD2024-06-28