FDA.report

Pomee

Primary DI
G1577122240
Brand
Pomee
Company
POMEE CORPORATION
Model
712-224
Catalog number
712-224
Device description
4 3/4" curved
Published
2021-12-23
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
EGNScissors, Surgical Tissue, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G1577122240PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. 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

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B382S3797050Surgical DirectSurgical Direct, Inc.EGN2026-03-09
B382S9038721000Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD9038721050Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD90390415L0Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD92011811070Surgical DirectSurgical Direct, Inc.EGN2026-03-02
G1493803706TBS DentalACME ENTERPRISE.EGN2026-03-02
G1493806507TBS DentalACME ENTERPRISE.EGN2026-03-02
B382S3488110Surgical DirectSurgical Direct, Inc.EGN2026-02-25
B382SD903220230Surgical DirectSurgical Direct, Inc.EGN2026-02-25
B382SD9032161010Surgical DirectSurgical Direct, Inc.EGN2026-02-20
B382SD9035171020Surgical DirectSurgical Direct, Inc.EGN2026-02-16
B382SD9036541000Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382SD90398411L0Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382SD90398511L0Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382S37921050Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382S37921060Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD59240Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6720800Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6720820Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6780830Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD80840Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9035401000Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD90378310040Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD90390214LH0Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD90391117LH0Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9039831050Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9039831060Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD909095200Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD909095230Surgical DirectSurgical Direct, Inc.EGN2026-02-03
D9283001200SCISSORS METZ 5 3/4" CRV DELICATE TCW.H. Holden, Inc.EGN2026-01-06