FDA.reportPublic FDA data

Symmetry Lambotte

Primary DI
00887482048221
Brand
Symmetry Lambotte
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
27-5704
Catalog number
27-5704
Device description
Symmetry® Osteotome, Mini-Lambotte, Straight, 4 mm, 5 1/8 in, 130 mm
Published
2022-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDGChisel (Osteotome)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482048221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482048221008874820482218874820482210887482048221

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.125Inch
Width4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD921381110Surgical DirectSurgical Direct, Inc.KDG2026-02-12
B382SD9144841130Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841180Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841190Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD921613120Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201100Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201110Surgical DirectSurgical Direct, Inc.KDG2025-11-05
00198506086465ELMED INCORPORATEDELMED INCORPORATEDKDG2025-11-05
B382SD62622020Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622040Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622060Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622070Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622080Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622090Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622100Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622120Surgical DirectSurgical Direct, Inc.KDG2025-10-14
00810158217577PRINCETONPrinceton Medical Group, Inc.KDG2025-10-08
00810158216938PRINCETONPrinceton Medical Group, Inc.KDG2025-09-10
10840199528834Comfort Plus ChiselKOROS U.S.A., INC.KDG2025-01-31
10888277381339MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10888277392304MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10840199511423ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199511430ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199527394OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527400OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527417OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527424OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527431OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527448OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527455OsteotomeKOROS U.S.A., INC.KDG2024-12-31