FDA.reportPublic FDA data

DORO® UNITY

Primary DI
04250435545287
Brand
DORO® UNITY
Company
Black Forest Medical GmbH
Model
1015.001
Device description
DORO® UNITY Skull Clamp
Published
2026-11-02
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

Product Codes#

Code, Name table
CodeName
HBLHolder, Head, Neurosurgical (Skull Clamp)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K262229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262229000DORO® Headrest System for AVABlack Forest Medical GmbH2026-10-27HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250435545287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250435545287042504355452874250435545287

Regulatory Flags#

DUNS number
313517922
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00425043554417DORO LUCENT® AVA Disposable Skull Pins1106.1212026-11-02
04250435545256DORO® UNITY1015.0402026-11-02
04250435545355DORO® UNITY1010.0402026-11-02
04250435545386DORO® UNITY1010.0012026-11-02
04250435545492DORO LUCENT®1110.0012026-11-02
04250435545522DORO LUCENT®1110.0402026-11-02
04250435545577DORO® AVA Sterile Disposable Skull Pins1006.0002026-11-02
04250435545584DORO® AVA Sterile Disposable Skull Pins1106.0202026-11-02
04250435545591DORO LUCENT® AVA Disposable Skull Pins1106.1202026-11-02
04250435546017DORO® AVA Sterile Disposable Skull Pins1006.0102026-11-02
04250435546024DORO® AVA Sterile Disposable Skull Pins1106.0302026-11-02
04250435546031DORO LUCENT® AVA Disposable Skull Pins1106.1302026-11-02
04250435545652DORO LUCENT® Disposable Skull Pins1106.1032026-10-29
04250435545669DORO® Sterile Disposable Skull Pins3006-002026-10-29
04250435545676DORO® Sterile Disposable Skull Pins3006-102026-10-29
04250435545683DORO® Sterile Disposable Skull Pins3006-202026-10-29
04250435545690DORO® Sterile Disposable Skull Pins3006-302026-10-29
04250435545706DORO® Disposable Skull Pins3006-502026-10-29
04250435500026DORO® Base Unit3001-001 2016-12-15
04250435500149DORO® Base Unit3001-0102016-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00425043554417DORO LUCENT® AVA Disposable Skull PinsBlack Forest Medical GmbHHBL2026-11-02
04250435545256DORO® UNITYBlack Forest Medical GmbHHBL2026-11-02
04250435545355DORO® UNITYBlack Forest Medical GmbHHBL2026-11-02
04250435545386DORO® UNITYBlack Forest Medical GmbHHBL2026-11-02
04250435545492DORO LUCENT®Black Forest Medical GmbHHBL2026-11-02
04250435545522DORO LUCENT®Black Forest Medical GmbHHBL2026-11-02
04250435545577DORO® AVA Sterile Disposable Skull PinsBlack Forest Medical GmbHHBL2026-11-02
04250435545584DORO® AVA Sterile Disposable Skull PinsBlack Forest Medical GmbHHBL2026-11-02
04250435545591DORO LUCENT® AVA Disposable Skull PinsBlack Forest Medical GmbHHBL2026-11-02
04250435546017DORO® AVA Sterile Disposable Skull PinsBlack Forest Medical GmbHHBL2026-11-02
04250435546024DORO® AVA Sterile Disposable Skull PinsBlack Forest Medical GmbHHBL2026-11-02
04250435546031DORO LUCENT® AVA Disposable Skull PinsBlack Forest Medical GmbHHBL2026-11-02
04250435545652DORO LUCENT® Disposable Skull PinsBlack Forest Medical GmbHHBL2026-10-29
04250435545669DORO® Sterile Disposable Skull PinsBlack Forest Medical GmbHHBL2026-10-29
04250435545676DORO® Sterile Disposable Skull PinsBlack Forest Medical GmbHHBL2026-10-29
04250435545683DORO® Sterile Disposable Skull PinsBlack Forest Medical GmbHHBL2026-10-29
04250435545690DORO® Sterile Disposable Skull PinsBlack Forest Medical GmbHHBL2026-10-29
04250435545706DORO® Disposable Skull PinsBlack Forest Medical GmbHHBL2026-10-29
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