FDA.report

Karl Schumacher

Primary DI
00842517119147
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
PPR6806A
Device description
Probe / Exp, Williams / #23 Exp
Published
2024-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EIXPROBE, PERIODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842517119147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517119147008425171191478425171191470842517119147

GMDN Terms

TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)523-2427custsvs@karlschumacher.com

Regulatory Flags

DUNS number
101070070
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00842517104747Karl SchumacherASP0016T2025-07-08
00842517112360Karl SchumacherNEE00022025-07-08
00842517112384Karl SchumacherNEE00062025-07-08
00842517112421Karl SchumacherNEE00082025-07-08
00842517112438Karl SchumacherNEE0008T2025-07-08
00842517112476Karl SchumacherNEE00112025-07-08
00842517112483Karl SchumacherNEE00122025-07-08
00842517116764Karl SchumacherSCI0667S2025-06-19
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23
00842517112629Karl SchumacherNEE06912025-04-23
00842517112780Karl SchumacherNEE07902025-04-23
00842517112803Karl SchumacherNEE07912025-04-23
00842517111417Karl SchumacherHEM06102025-02-05
00842517111424Karl SchumacherHEM06112025-02-05
00842517112209Karl SchumacherMOS06122025-02-05
00842517112216Karl SchumacherMOS06132025-02-05
00842517103603Karl SchumacherAMCBGMS2024-09-19

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