FDA.report

Busse Hospital Disposables

Primary DI
10849233003252
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
1168
Catalog number
1168
Device description
Arthrogram Tray
Published
2020-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OIIArthrogram Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OIIArthrogram TrayRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10849233003252PackageGS110In Commercial Distribution
00849233003255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923300325210849233003252
00849233003255008492330032558492330032550849233003255

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various sterile surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
002418234
Device count
1
DM exempt
false
Premarket exempt
false
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

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