FDA.reportPublic FDA data

Tecno

Primary DI
08964003293567
Brand
Tecno
Company
TECNO INSTRUMENTS (PVT) LTD
Model
130-134
Device description
Kogan Endocervical Retractor (4 mm)
Published
2024-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDLRetractor, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003293567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003293567089640032935678964003293567

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+92523552723info@tecno.com.pk

Regulatory Flags#

DUNS number
645519047
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08964003294458Tecno110-140-072025-08-18
08964003293383Tecno130-1802024-07-04
08964003293390Tecno130-1812024-07-04
08964003293406Tecno130-1822024-07-04
08964003293413Tecno130-1832024-07-04
08964003293420Tecno130-185 ET2024-07-04
08964003293437Tecno130-186 ET2024-07-04
08964003293444Tecno130-1852024-07-04
08964003293451Tecno130-1862024-07-04
08964003293468Tecno130-1752024-07-03
08964003293475Tecno130-1702024-07-03
08964003293482Tecno130-1762024-07-03
08964003293499Tecno130-1782024-07-03
08964003293505Tecno130-1792024-07-03
08964003293512Tecno130-1202024-07-03
08964003293529Tecno130-1222024-07-03
08964003293536Tecno130-1242024-07-03
08964003293543Tecno130-1262024-07-03
08964003293550Tecno130-1332024-07-03
08964003293574Tecno130-1352024-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436339MillenniumAvalign Technologies, Inc.HDL2026-10-08
00190776434540MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776434557MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776434564MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776434571MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776435905MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776431280MillenniumAvalign Technologies, Inc.HDL2026-09-22
00190776432126MillenniumAvalign Technologies, Inc.HDL2026-09-22
00190776432133MillenniumAvalign Technologies, Inc.HDL2026-09-22
00190776423957MillenniumAvalign Technologies, Inc.HDL2026-08-27
00190776407421MillenniumAvalign Technologies, Inc.HDL2026-07-31
00190776400507MillenniumAvalign Technologies, Inc.HDL2026-07-19
15060557440317Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440423Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440430Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440447Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440454Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440062Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440147Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440154Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
45060557440066Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
65060557440060Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440300Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440393Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
25060557440055Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
45060557440059Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
65060557440053Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440003Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440072Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440089Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26