FDA.report

SURGIPROS

Primary DI
00810212930497
Brand
SURGIPROS
Company
Surgipros, LLC
Model
FB882SP
Device description
SAURBRUCH RIB SHEARS 10 1/2" STRAIGHT
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTZInstrument, Cutting, Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810212930497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810212930497008102129304978102129304970810212930497

GMDN Terms

TermDefinition
Bone cutterA strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
410-960-0452info@surgipros.com

Regulatory Flags

DUNS number
058689193
Device count
1
DM exempt
true
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
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

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00810212930534SURGIPROS50-4680SP2026-05-22
00810212930664SURGIPROSBC915SP2026-05-23
00810212930671SURGIPROSBC919SP2026-05-23
00810212930725SURGIPROSBC924SP2026-05-23
00810212931340SURGIPROSFB402T2026-05-22
00810212933054SURGIPROSEA016T2026-05-22
00810143905052SURGIPROS7803-65SP2024-09-18
00810143905113SURGIPROS9009-13SP2024-09-18
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00810143905137SURGIPROS3092SP2024-09-18
00810143905144SURGIPROS3099SP2024-09-18
00810143905151SURGIPROS3101SP2024-09-18

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10603295553694ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
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