FDA.report

TSplitter, 10MM x 310MM

Primary DI
00810012485074
Brand
TSplitter, 10MM x 310MM
Company
BIOPRO, INC.
Model
95-7541
Published
2019-06-10
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
EMMChisel, Osteotome, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810012485074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810012485074008100124850748100124850740810012485074

GMDN Terms

TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
618749857
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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