FDA.report

DeRoyal

Primary DI
50749756800513
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
28-0223B
Catalog number
28-0223B
Device description
Adapter, Stryker- Bulk
Published
2021-06-30
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

Related Records

Contact Domains

Product Codes

CodeName
NKCTubing/tubing with filter, insufflation, laparoscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756800513PackageGS120In Commercial Distribution
00749756800518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975680051350749756800513
00749756800518007497568005187497568005180749756800518

GMDN Terms

TermDefinition
Insufflation gas conditioning tubing setA collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.

Sterilization Methods

Method

Contacts

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
false
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 DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840493412498RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
00840493412535RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
15060120950571Insufflation FilterGVS FILTER TECHNOLOGY UK LTDNKC2025-12-11
26931918171255AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2025-12-09
04711605992053The O R Company - InsufflatOR Tubing SetADVANCED MEDICAL DESIGN CO., LTD.NKC2025-07-28
04048551067444NAKarl Storz GmbH & Co. KGNKC2025-03-28
04048551326664NAKarl Storz GmbH & Co. KGNKC2025-03-28
10817183020810PUREPNEUMO Tubing SetNORTHGATE TECHNOLOGIES INC.NKC2024-07-09
04055207070109NARichard Wolf GmbHNKC2024-05-24
14897106955869andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-30
14897106955852andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-28
50628725007361CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007378CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007385CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007392CHSCanadian Hospital Specialties LimitedNKC2023-08-23
20326053102787Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
20326053102800Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
20326053102817Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
26931918199655AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2023-07-20
B382SD500011Surgical DirectSurgical Direct, Inc.NKC2022-12-03
B382SD50001M0Surgical DirectSurgical Direct, Inc.NKC2022-12-03
B382SD50001S0Surgical DirectSurgical Direct, Inc.NKC2022-12-03
B382SD500041Surgical DirectSurgical Direct, Inc.NKC2022-12-03
B382SD500001Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50000M0Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50000S0Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD500021Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50002S0Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50003S0Surgical DirectSurgical Direct, Inc.NKC2022-11-30
B382SD50004S0Surgical DirectSurgical Direct, Inc.NKC2022-11-30