FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756260947
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
TSR-1
Catalog number
TSR-1
Device description
Skin Staple Remover
Published
2021-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756260948PackageGS112In Commercial Distribution
50749756260942PackageGS124In Commercial Distribution
00749756260947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975626094830749756260948
5074975626094250749756260942
00749756260947007497562609477497562609470749756260947

GMDN Terms#

Term, Definition table
TermDefinition
Skin staple remover, single-useA hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of metallic or synthetic polymer materials with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. 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
Kit
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
00749756281850DeRoyal77-40026077-4002602021-07-12
00749756281867DeRoyal77-4002612016-09-12
00749756281898DeRoyal77-4002642016-09-12
00749756609616DeRoyal35-4034152016-09-12
00749756650922DeRoyal12-0018552016-09-12
00749756656474DeRoyal77-4002662016-09-12
00749756402316DeRoyalNP-6006ULNP-6006UL2026-10-16
00749756402323DeRoyalNP-6007ULNP-6007UL2026-10-16
00749756402330DeRoyalNP-6008ULNP-6008UL2026-10-16
00749756402347DeRoyalNP-0080ULNP-0080UL2026-10-16
00749756402354DeRoyalNP-6014ULNP-6014UL2026-10-16
00749756402361DeRoyalNP-6015ULNP-6015UL2026-10-16
00749756402378DeRoyalNP-6016ULNP-6016UL2026-10-16
00749756402989DeRoyalNP-0250UNP-0250U2026-09-30
00749756402996DeRoyalNP-0450UNP-0450U2026-09-30
00749756403009DeRoyalNP-0450UNNP-0450UN2026-09-30
00749756403016DeRoyalNP-0250UNNP-0250UN2026-09-30
00749756403023DeRoyalNP-0250U-01NP-0250U-012026-09-30
00749756403375DeRoyal31-120P31-120P2026-09-30
00749756369640DeRoyalNP-7000NP-70002026-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160541739HALYARDMEDICAL ACTION INDUSTRIES INC.KDD2026-10-26
00850074437208OftalOnePackOFTAL-ONE INC.KDD2026-10-21
00749756400442DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-21
00749756394666DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756397193DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401708DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401715DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00889795154668Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154675Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154682Primal OCDParagon 28, Inc.KDD2026-07-14
20653405990328Infinity™Conmed CorporationKDD2026-06-10
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
B562PKGS000100Micro Surgery KitWishbone Medical, Inc.KDD2024-12-30
B562PKGS000200Minor Surgery KitWishbone Medical, Inc.KDD2024-12-30
08800071700166Tiger GuardKims Med Co.,Ltd.KDD2024-10-21
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
08800071700050EZ Fan Funnel 2KimsMed Co.,Ltd.KDD2023-02-06
10885380194108Aero-MedAERO-MED, LLCKDD2022-12-15
40801902130233ARROWTELEFLEX INCORPORATEDKDD2022-12-14