FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756166379
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
72-7100NS
Catalog number
72-7100NS
Device description
Amniotic Membrane Perforator
Published
2021-07-12
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
HGEAmniotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGEAmniotomeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756166374PackageGS1500In Commercial Distribution
00749756166379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975616637450749756166374
00749756166379007497561663797497561663790749756166379

GMDN Terms#

Term, Definition table
TermDefinition
Amniotic membrane perforator, single-useA surgical instrument used to rupture the amniotic membrane (i.e., the amnion - the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid) to assist in childbirth, without causing injury to the mother or foetus. It is typically long and shaft-like, and terminates in a rounded nose with a sharp hook. It is made of plastic materials, and may be straight or curved to follow the natural contours of the birthing canal into which it is inserted. Amniotic membrane rupture may also be performed using an amniotome or forceps and/or a trocar. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047043737GimmiGimmi GmbHHGE2025-05-13
M803020301MedGyn Disposable Amnio HookMEDGYN PRODUCTS, INC.HGE2024-04-30
00849233010505BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HGE2023-08-09
10849233010502BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HGE2023-08-09
07898506815289QuinelatoSchobell Industrial LtdaHGE2023-07-05
00840113231485Amnihook Amniotic Membrane PerforatorASPEN SURGICAL PRODUCTS, INC.HGE2023-02-27
00888937014761mityhookCoopersurgical, Inc.HGE2022-12-01
00749756166362DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
50749756166367DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
50749756166374DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
10767056096018Mabis DMID-M-S HOLDINGS, INC.HGE2021-05-19
00827002343122ObstiHookCOOK INCORPORATEDHGE2020-10-02
10827002343129ObstiHookCOOK INCORPORATEDHGE2020-10-02
H671AR1000AROM-COTUTAH MEDICAL PRODUCTS, INC.HGE2020-06-04
H671AR2000AROM-COTUTAH MEDICAL PRODUCTS, INC.HGE2020-06-04
04038653155002AESCULAPAesculap AGHGE2020-05-08
10381780506706Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHGE2018-09-12
H8343022600Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHGE2018-09-12
09350902000174AmnicotGO MEDICAL INDUSTRIES PTY. LTD.HGE2016-09-24
09350902000211AmnicotGO MEDICAL INDUSTRIES PTY. LTD.HGE2016-09-24