FDA.report

Busse Hospital Disposables

Primary DI
10849233010366
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
9809
Catalog number
9809
Device description
Lumbar Puncture Tray
Published
2020-04-09
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

Contact Domains

Product Codes

CodeName
FMJManometer, Spinal-Fluid

Product Code Classifications

CodeDeviceSpecialtyClass
FMJManometer, Spinal-FluidGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10849233010366PackageGS110In Commercial Distribution
00849233010369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301036610849233010366
00849233010369008492330103698492330103690849233010369

GMDN Terms

TermDefinition
Lumbar puncture kitA collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1 (631) 435-4711mail@busseinc.com

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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00849233008779Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-10
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