FDA.report

Battery

Primary DI
00192896112124
Brand
Battery
Company
SONTEC INSTRUMENTS, INC.
Model
100-5502
Device description
Battery Only for #100-5500
Published
2021-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FSPLOUPE, DIAGNOSTIC/SURGICAL
HPPHeadlamp, Operating, Battery-Operated

Product Code Classifications

CodeDeviceSpecialtyClass
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery1
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896112124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896112124001928961121241928961121240192896112124

GMDN Terms

TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder or container intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. It is typically used during a transport situation (e.g., a neonatal incubator), or when the device is designed to power a cordless devices (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
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
true
Sterilization required before use
true

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00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
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00850036373407Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373414Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373421Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373438Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373445Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373452Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00723896025321TTL Easy Size 2.5X Loupes RedPRACTICON, INC.FSP2026-01-07
00723896025338TTL Easy Size 3.0X Loupes RedPRACTICON, INC.FSP2026-01-07
00723896025505TTL Easy Size 2.5X Loupes SilverPRACTICON, INC.FSP2026-01-07
00723896025512TTL Easy Size 3.0X Loupes SilverPRACTICON, INC.FSP2026-01-07
00723896030097TTL Easy Size 2.5X Loupes BlackPRACTICON, INC.FSP2026-01-07
00723896030103TTL Easy Size 3.0X Loupes BlackPRACTICON, INC.FSP2026-01-07
00810186670146Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670153Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670160Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670177Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670184Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670191Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670207Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
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00194613122690MSI Precision Specialty InstrumentsMed Saver, Inc.HPP2025-08-01
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