FDA.report

BO-SonoInject

Primary DI
04048223027189
Brand
BO-SonoInject
Company
Pajunk GmbH Medizintechnologie
Model
001188-81
Catalog number
001188-81
Device description
BO-SonoInject 25G (0,50) x 50mm cornerstone reflectors, with cable 90cm
Published
2020-08-28
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
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048223050866PrimaryGS10
14048223027186PrimaryGS10
04048223027189Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048223050866040482230508664048223050866
1404822302718614048223027186
04048223027189040482230271894048223027189

GMDN Terms

TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)972-5865info@pajunk-usa.com
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags

DUNS number
317654283
Device count
10
DM exempt
false
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
04048223126103NerveStim Pure1151-94-901151-94-902026-02-06
04048223128817SPROTTE®511151-29A511151-29A2025-09-16
04048223129111SPROTTE® NRFit051163-29A051163-29A2025-09-16
04048223129517SPROTTE® NRFit041163-29A041163-29A2025-09-16
04048223129647SPROTTE®071151-30C071151-30C2025-09-16
04048223129678SPROTTE® NRFit021163-30C021163-30C2025-09-16
04048223129692SPROTTE® NRFit031163-27A031163-27A2025-09-16
04048223129838SPROTTE® NRFit061163-29A061163-29A2025-09-16
04048223129999Standard Sprotte Needle321151-29A321151-29A2025-09-16
04048223131398Standard Sprotte Needle341151-31B341151-31B2025-09-16
04048223131428SPROTTE®131151-30C131151-30C2025-09-16
04048223131442SPROTTE®131151-30A131151-30A2025-09-16
04048223131466SPROTTE®141151-30C141151-30C2025-09-16
04048223132050SonoPlex® II Facet S001287-72001287-722025-09-16
04048223132135SonoPlex® II Facet S001287-76001287-762025-09-16
04048223132241SonoPlex® II Facet NRFit001265-74001265-742025-09-16
04048223132319SonoPlex® II Facet NRFit001265-77001265-772025-09-16
04048223132395SonoPlex® II Facet001285-76001285-762025-09-16
04048223132463SonoBlock II Facet001280-74001280-742025-09-16
04048223132562SonoPlex® II Facet S NRFit001267-76001267-762025-09-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50192253036877MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036880MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036897MonojectCardinal Health 200, LLCGAA2026-03-23
50192253036907MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036934MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036941MonojectCardinal Health 200, LLCGAA2026-03-23
50192253036952MonojectCardinal Health 200, LLCGAA2026-03-23
50198956355451CARDINAL HEALTHCardinal Health 200, LLCGAA2026-03-19
MHC18018250EasyTouchMHC MEDICAL PRODUCTS, LLCGAA2026-03-17
00810235030860US Accessory KitMERZ NORTH AMERICA, INC.GAA2026-03-05
00810235030877US Rigid Needle with Support Cannula- Double BevelMERZ NORTH AMERICA, INC.GAA2026-03-05
00810235030884US Rigid Injection Needle with Huber PointMERZ NORTH AMERICA, INC.GAA2026-03-05
20850083784403Comfort EZS.D.I. USA, INC.GAA2026-02-13
50192253036860MonojectCardinal Health 200, LLCGAA2026-02-10
50192253036976MonojectCardinal Health 200, LLCGAA2026-02-10
50192253025260MonojectCardinal Health 200, LLCGAA2026-01-16
50198956310047CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-26
50198956290554CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-17
50198956168808CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-11
04046964941245Filter Straw®B. BRAUN MEDICAL INC.GAA2025-12-09
06938695502155Bone DrillShanghai Kinetic Medical Co., Ltd.GAA2025-12-09
06938695527004Bone DrillShanghai Kinetic Medical Co., Ltd.GAA2025-12-09
04046964943232NAB. BRAUN MEDICAL INC.GAA2025-12-02
04046964941221Filter Straw®B. BRAUN MEDICAL INC.GAA2025-12-02
50198956273182CARDINAL HEALTHCardinal Health 200, LLCGAA2025-11-14
04250676736109VoiceInject injection needleSpiggle & Theis Medizintechnik GmbHGAA2025-09-09
08800176592673WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592680WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592697WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592703WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08