FDA.report

N/A

Primary DI
00817438024658
Brand
N/A
Company
Omega Surgical Instruments Inc
Model
R60-51N
Device description
6.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR W/J-NOTCH, 8 FLUTE
Published
2022-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GFFBur, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817438024658PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
8106959800complaints@omegasurgical.com

Regulatory Flags

DUNS number
808825038
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00817438028632N/AMR14BA302025-11-13
00817438028649N/AMR14BA30D2025-11-13
00817438028540N/ASM-35142025-09-09
00817438028571N/ASS-35142025-09-09
00817438028588N/AZMS-35142025-09-09
00817438028502N/APTR-3245-02R2025-08-19
00817438028595N/ASM-30582025-07-23
00817438028601N/AZMS-30582025-07-23
00817438028090N/AMR10BA40D2025-07-22
00817438028281N/AMR9AC752025-07-22
00817438028557N/AMR14BA50D2025-07-22
00817438028120N/AMR14BA402025-07-08

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24053613295936Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296131Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296193Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296803Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
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24053613297190Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297206Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297220Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
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04027497285884GT PODO 0.276 in (7 mm) round Shank 3/32"LUKAS-ERZETT GmbH & Co. KGGFF2026-02-11
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