FDA.reportPublic FDA data

DORO LUCENT® Disposable Skull Pins

Primary DI
04250435545652
Brand
DORO LUCENT® Disposable Skull Pins
Company
Black Forest Medical GmbH
Model
1106.103
Device description
DORO LUCENT® Sterile Disposable Skull Pins, Adult (9 pcs)
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

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
K191740000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191740000DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH2020-02-21HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250435545652PrimaryGS10
04250435545645Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250435545652042504355456524250435545652
04250435545645042504355456454250435545645

Regulatory Flags#

DUNS number
313517922
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00425043554417DORO LUCENT® AVA Disposable Skull Pins1106.1212026-11-02
04250435545256DORO® UNITY1015.0402026-11-02
04250435545287DORO® UNITY1015.0012026-11-02
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
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
04250435545287DORO® 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
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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