FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756885794
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-8817
Device description
PAIN PACK
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGJNerve block tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756885794PackageGS15In Commercial Distribution
00749756885799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975688579450749756885794
00749756885799007497568857997497568857990749756885799

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia single-administration set, non-medicatedA collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS196900Aligned Medical SolutionsAligned Medical SolutionsOGJ2026-09-25
10198956571822CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-22
10198956541917CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-21
10198956564176CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-21
10198956509498CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
10198956561878CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
B098AMS190500Aligned Medical SolutionsAligned Medical SolutionsOGJ2026-08-21
04046955966370Design Options®B. BRAUN MEDICAL INC.OGJ2026-08-17
00849233018099Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-08-14
10198956516755CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10198956533219CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10198956429512CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956470545CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956523760CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956530447CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956533493CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
00628725050287Nerve Block Tray Clint PharmaceuticalsCHS USA Inc.OGJ2026-07-20
00628725050294Nerve Block Tray Clint PharmaceuticalsCHS USA Inc.OGJ2026-07-20
10198956530010CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-20
00628725050188Nerve Block TrayCHS USA Inc.OGJ2026-07-17
00628725050195Nerve Block TrayCHS USA Inc.OGJ2026-07-17
00628725050201Nerve Block TrayCHS USA Inc.OGJ2026-07-17
10198956500785CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-09
10198956524620CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-09
04046955966394Design Options®B. BRAUN MEDICAL INC.OGJ2026-06-25
00849233017948Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-06-23
10198956481176CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-05
10198956458451CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-01
00849233014329Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-03-25
00628725050003Nerve Block TrayCHS USA Inc.OGJ2025-11-20