Home GUDID 00842331154324 Novo Surgical Inc.
Primary DI 00842331154324
Brand Novo Surgical Inc.
Company NOVO SURGICAL, INC.
Model OB6338-63
Catalog number OB6338-63
Device description heaney hysterectomy retractor, blade 1 1/8" x 2 7/8" deep (2.9 cm x 7.3 cm), 6 3/4" (17.0 cm)
Published 2022-11-12
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 true Product Codes# Code, Name table Code Name HDL Retractor, Vaginal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HDL Retractor, Vaginal Obstetrics/Gynecology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842331154324 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00842331154324 00842331154324 842331154324 0842331154324
GMDN Terms# Term, Definition table Term Definition Vaginal rectocele reduction instrument A non-sterile, hand-held, retractor-like device intended to be used to manually reduce a rectocele (herniation of lower bowel/rectum through a vaginal wall tear) during defecation to facilitate bowel emptying. It is intended to be used by direct application into the vagina by the patient during routine self-treatment to replace digital reduction and as an alternative to the more permanent pessary or surgical repair. It is typically made of plastic material and can be reused after appropriate cleaning.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 033029433 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 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198506089039 ELMED INCORPORATED ELMED INCORPORATED HDL 2026-03-03 00198506089046 ELMED INCORPORATED ELMED INCORPORATED HDL 2026-03-03 00198506088797 ELMED INCORPORATED ELMED INCORPORATED HDL 2026-02-25 00198506088827 ELMED INCORPORATED ELMED INCORPORATED HDL 2026-02-25 00198506087240 ELMED INCORPORATED ELMED INCORPORATED HDL 2025-12-18 00190776409364 Millennium Avalign Technologies, Inc. HDL 2025-08-28 00190776414535 Millennium Avalign Technologies, Inc. HDL 2025-08-15 00190776414542 Millennium Avalign Technologies, Inc. HDL 2025-08-15 00190776414566 Millennium Avalign Technologies, Inc. HDL 2025-08-15 00190776414580 Millennium Avalign Technologies, Inc. HDL 2025-08-15 00190776414597 Millennium Avalign Technologies, Inc. HDL 2025-08-15 00190776414603 Millennium Avalign Technologies, Inc. HDL 2025-08-15 00190776414627 Millennium Avalign Technologies, Inc. HDL 2025-08-15 00190776414634 Millennium Avalign Technologies, Inc. HDL 2025-08-15 00190776414641 Millennium Avalign Technologies, Inc. HDL 2025-08-15 00194613033224 MSI Precision Specialty Instruments Med Saver, Inc. HDL 2025-08-01 00194613065737 MSI Precision Specialty Instruments Med Saver, Inc. HDL 2025-08-01 00194613117894 MSI Precision Specialty Instruments Med Saver, Inc. HDL 2025-08-01 00194613124205 MSI Precision Specialty Instruments Med Saver, Inc. HDL 2025-08-01 00190776406677 Millennium Avalign Technologies, Inc. HDL 2025-07-23 00190776394622 Millennium Avalign Technologies, Inc. HDL 2025-05-07 00190776394639 Millennium Avalign Technologies, Inc. HDL 2025-05-07 00190776392680 Millennium Avalign Technologies, Inc. HDL 2025-05-02 00194613065355 MSI Precision Specialty Instruments Med Saver, Inc. HDL 2025-03-21 00198506081163 ELMED INCORPORATED ELMED INCORPORATED HDL 2025-03-12 00198506081170 ELMED INCORPORATED ELMED INCORPORATED HDL 2025-03-12 00198506075360 ELMED INCORPORATED ELMED INCORPORATED HDL 2025-02-18 00850071684254 Realstar Surgical REAL STAR SURGICAL INSTRUMENTS HDL 2025-01-21 00198506074462 ELMED INCORPORATED ELMED INCORPORATED HDL 2025-01-20 00198506074479 ELMED INCORPORTED ELMED INCORPORATED HDL 2025-01-20
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