BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

BLO-K

DI: G635812020 · Model: 20 Ga x 20 cm · HISTO S.A.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: BLO-K
Primary DI: G635812020
Version / Model: 20 Ga x 20 cm
Catalog Number: 812020
Company Name: HISTO S.A.
Labeler DUNS: 971156914
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2024-05-17
Public Version: 1
Public Version Date: 2024-05-27
Public Version Status: New
Public Device Record Key: 0eb57bb2-3c9a-44c4-8471-5f79534a7895

Device Description

Prostate Anesthesia needle BLO-K

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35212	Spinal needle, single-use	A sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	G6358120202	HIBCC	BOX	10	In Commercial Distribution
Primary	G635812020	HIBCC

Customer Contacts

Phone: +540114712541
Email: [email protected]

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 15 – 85 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal
Type: Storage Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 95 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal