Individual Ancillary Item Kit

Primary DI
B875700
Brand
Individual Ancillary Item Kit
Company
Custom Interventional Pain Management, LLC
Model
70
Catalog number
70
Device description
Convenience kit non-medicated
Published
2023-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGDCustom Anesthesia Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGDCustom Anesthesia TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B875700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
030406006
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B87560LID0Discseel60LID60LID2023-08-15
B875DSCLID0DiscseelDSCLIDDSCLID2023-08-15
B875170Epidural Anesthesia Kit17172023-07-19
B87517LID0Epidural Anesthesia Kit17LID17LID2023-07-19
B875180Epidural Anesthesia Kit18182023-07-19
B87518LID0Epidural Anesthesia Kit18LID18LID2023-07-19
B875200Epidural Anesthesia Kit20202023-07-19
B87520LID0Epidural Anesthesia Kit20LID20LID2023-07-19
B875220Epidural Anesthesia Kit22222023-07-19
B87522LID0Epidural Anesthesia Kit22LID22LID2023-07-19
B875300Nerve Block Tray30302023-07-19
B87530LID0Nerve Block Tray30LID30LID2023-07-19
B875310Custom Anesthesia Tray31312023-07-19
B87531LID0Custom Anesthesia Tray31LID31LID2023-07-19
B87534040Bone Access Kit340434042023-07-19
B875400Continuous Regional Anesthesia Kit40402023-07-19
B87540LID0Continuous Regional Anesthesia Kit40LID40LID2023-07-19
B875410Spinal Anesthesia Kit41412023-07-19
B87541LID0Spinal Anesthesia Kit41LID41LID2023-07-19
B875500Refill Tray50502023-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194717116219Regard™ROI CPS, LLCOGD2022-10-05
10194717115106Regard™ROI CPS, LLCOGD2022-03-22
10194717113881Regard™ROI CPS, LLCOGD2021-11-19
10195594417451CARDINAL HEALTHCardinal Health 200, LLCOGD2021-11-05
10193489361940Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGD2021-08-27
10194717112761Regard™ROI CPS, LLCOGD2021-07-28
10194717110590Regard™ROI CPS, LLCOGD2021-05-10
10194717109730Regard™ROI CPS, LLCOGD2021-02-15
10194717109372Regard™ROI CPS, LLCOGD2021-01-14
10194717108924RegardROI CPS, LLCOGD2020-12-10
10194717107675Regard™ROI CPS, LLCOGD2020-06-25
10194717106982Regard™ROI CPS, LLCOGD2020-01-23
10194717101222Regard™ROI CPS, LLCOGD2019-12-23
10194717103042Regard™ROI CPS, LLCOGD2019-12-10
10194717102434Regard™ROI CPS, LLCOGD2019-11-01
10326053117340Regard™Resource Optimization & Innovation, L.L.C.OGD2019-09-18
10326053114363Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2018-03-28
10326053108713Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-23
10326053108737Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-23
10326053100885Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-21
10326053108317Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-20
10326053107129Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-05
10809160109212AVID TruCustomAVID MEDICAL, INC.OGD2016-10-11
10809160108284AVID TruCustomAVID MEDICAL, INC.OGD2016-10-04
10809160108031AVID TruCustomAVID MEDICAL, INC.OGD2016-10-03
10809160107317AVID TruCustomAVID MEDICAL, INC.OGD2016-09-28
10809160106143AVID TruCustomAVID MEDICAL, INC.OGD2016-09-20
10809160105177AVID TruCustomAVID MEDICAL, INC.OGD2016-09-19
10809160088395AVID TruCustomAVID MEDICAL, INC.OGD2016-09-15
10809160088708AVID TruCustomAVID MEDICAL, INC.OGD2016-09-15