FDA.reportPublic FDA data

Tecomet

Primary DI
00841435104372
Brand
Tecomet
Company
TECOMET INC.
Model
52770
Device description
GELPI RETRACTOR 7 1/2" BLUNT POINTS
Published
2020-10-13
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

Product Codes#

Code, Name table
CodeName
HTEElevator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841435104372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841435104372008414351043728414351043720841435104372

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078749695
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841435111509Tecomet482742026-03-02
00841435120402Tecomet004808020012026-02-27
00841435122574Tecomet004803105002026-02-27
00841435124929Tecomet800-08-0182026-02-26
00841435111554TecometTLG132075-J2025-11-14
00841435124295Tecomet004816002012025-09-15
00841435124912TecometAR-9938-112025-09-05
00841435111080Tecomet465722025-08-27
00841435111103Tecomet479312025-08-27
00841435111127Tecomet482422025-08-27
00841435111134Tecomet482442025-08-27
00841435111141Tecomet482452025-08-27
00841435111158Tecomet482462025-08-27
00841435111165Tecomet482542025-08-27
00841435111172Tecomet482482025-08-27
00841435111189Tecomet482592025-08-27
00841435111202Tecomet482692025-08-27
00841435118263Tecomet004819011002025-08-27
00841435118287Tecomet004819014002025-08-27
00841435118317TecometK000-20102025-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862659507N/AExactech, Inc.HTE2026-03-19
10885862661364NovationExactech, Inc.HTE2026-03-19
M93072015102SF20Life InstrumentsLife Instrument CorporationHTE2026-03-06
M93072015342S20Life InstrumentsLife Instrument CorporationHTE2026-03-06
M93072015342SF20Life InstrumentsLife Instrument CorporationHTE2026-03-06
00840277133373Innomed, Inc.INNOMED, INC.HTE2026-02-26
00840277133380Innomed, Inc.INNOMED, INC.HTE2026-02-26
00190776416539MillenniumAvalign Technologies, Inc.HTE2026-02-16
03662663109468Mergence-A Preparation InstrumentationHighridge Medical, LLCHTE2026-02-11
00190376539003Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTE2026-02-10
M93072513543B0Life Instruments Life Instrument CorporationHTE2026-02-02
00840180545096General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840180545102General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840180545119General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840277133151Innomed, Inc.INNOMED, INC.HTE2026-01-16
00840180543313General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543320General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543337General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543344General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543351General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543368General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
03662663156905SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHTE2025-12-29
00199150051687Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
00199150051694Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
00199150051700Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
03662663272186Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272193Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272209Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272216Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272223Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18