FDA.report

Pomee

Primary DI
G1577082620
Brand
Pomee
Company
POMEE CORPORATION
Model
708-262
Catalog number
708-262
Device description
Perry Plier 5" serrated tip
Published
2022-01-04
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
EMJElevator, Surgical, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G1577082620PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental articulation paper forcepsA hand-held manual dental instrument designed for grasping and holding articulation paper during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. 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
00348783004069Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004076Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004182Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004229Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00192896122772Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
00192896122789Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
G1493803201TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493803302TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493801502TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801704TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801805TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801906TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802200TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802301TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802402TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802503TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802604TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803100TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803403TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803504TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803605TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493807104TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493809106TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493850102TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493850203TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493850304TBS DentalACME ENTERPRISE.EMJ2026-03-02
G149TBSRPKIT00TBS DentalACME ENTERPRISE.EMJ2026-03-02
00840018672369Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMJ2026-02-11
00840018667556Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMJ2026-02-10
00840018666535Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMJ2026-02-09